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Imagerayi

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041580

by Henry Schein, Inc.

Identifiers

510(k) Number
K041580 FDA 510(k)
FDA Product Code
MUH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.1800 FDA 510(k)
Regulation Number
872.1800 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ImageRAYi is a digital extraoral X-ray system designed for dental imaging. It captures high-resolution radiographic images of the maxillofacial region, aiding in the diagnosis and treatment planning for dental and maxillofacial conditions. This system integrates a digital sensor with an X-ray source to provide clear, detailed images for clinical assessment.

The ImageRAYi is intended for use in dental offices and clinics, where it is operated by trained dental professionals. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance. The system is non-reusable and supplied as a sterile or non-sterile device depending on the specific components, with no indication of MRI compatibility. Multiple sensor models are available, each referenced by unique FEI numbers, and the device is regulated under FDA regulation number 872.1800.

Frequently asked questions

What types of dental and maxillofacial conditions can the ImageRAYi help diagnose or plan treatment for?

The ImageRAYi is designed to capture high-resolution radiographic images of the maxillofacial region, which aids in diagnosing dental and maxillofacial conditions such as tooth decay, bone abnormalities, impacted teeth, and other structural issues. It supports treatment planning by providing clear visualizations needed for procedures like extractions, orthodontics, or surgical interventions.

Is the ImageRAYi system reusable, or is it intended for single-use only?

The ImageRAYi is explicitly stated as a non-reusable device. Components like the digital sensor are intended for single-use, ensuring hygiene and reducing cross-contamination risks in clinical settings.

How many sensor models are available for the ImageRAYi, and how do I identify them?

The ImageRAYi offers multiple sensor models, each identified by a unique FEI number (e.g., 3000190675, 3038718579, etc.). These numbers are listed in the FDA’s regulatory records under the product code MUH and regulation 872.1800. The exact model determines sensor size and compatibility with the system.

Are the sensors for the ImageRAYi sterile or non-sterile, and how should they be stored?

The ImageRAYi sensors are supplied as either sterile or non-sterile, depending on the specific model or packaging. Since they are non-reusable, proper storage instructions (e.g., sealed packaging, dry environment) are critical to maintain integrity until use. Always refer to the manufacturer’s guidelines for storage conditions.

What regulatory pathway did the ImageRAYi follow to gain market authorization in the U.S., and what does that mean for clinicians?

The ImageRAYi received FDA 510(k) clearance under the Traditional Review pathway, classified as a Class II medical device for dental use. This means it was deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and performance standards for extraoral digital X-ray systems. Clinicians can rely on its compliance with established regulatory requirements.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Henry Schein, Inc. - Investor Relations, IMAGERAYI (K041580) — FDA 510(k) | Innolitics, Imaging - Henry Schein Medical, Henry Schein, Inc. -

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (1)

  • FDA 510(k) K041580 24 fields · synced Sep 19, 2026